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At present, in order to cope with the global pandemic of the COVID-19 virus, governments have introduced corresponding measures, COVID-19 lockdown is one of the most important measures. However, lockdown makes the management of chronic diseases (such as type 2 diabetes) more difficult, and telemedicine may be one of the solutions. We hope to explore the effect of telemedicine on blood glucose control and other prognostic indicators of young and middle-aged obese patients with type 2 diabetes who will experience isolation control.
We recruit patients with type 2 diabetes who need to be isolated due to the COVID-19 epidemic, Our study will include young and middle-aged obese patients. The lockdown period is 21 days. The patients will be randomly divided into two groups with a total follow-up time of 6 months. One group is the telemedicine intervention group, and the other group is the routine follow-up control group. The intervention group used the hospital telemedicine management system to upload blood glucose values (fasting and 2h after three meals), food intake of three meals, and exercise volume (Data collection frequency: first three months, 4 times/week; 4-6 Month, 2 times/week).Doctors will collect data from hospital telemedicine management system to guide patients on diets, exercise, and medication adjustments. The control group will be followed up by telephone/outpatient clinic every 1 week. (only telephone follow-up will be conducted during the lockdown period) Then doctors will collect their blood glucose values.(fasting and 2h after three meals) Based on the data collected, The doctors will provide lifestyle guidance to the patients on the telephone or face to face. The clinical data of the two groups of patients will be collected at baseline, 22 days, 3 months, and 6 months respectively. (HbA1c, fasting blood glucose(FBG), blood glucose 2 hours after breakfast, blood pressure, Body Mass Index(BMI), waist-to-hip ratio, total cholesterol(TC), triglyceride(TG), high-density lipoprotein cholesterol(HDL-C), low-density lipoprotein cholesterol(LDL-C), Blood Urea Nitrogen(BUN), serum creatinine(Scr), e-GFR, Self-rating Depression Scale, frequency of hypoglycemia，and Cost effectiveness) The clinical data will be statistically analyzed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telemedicine | Experimental | Diabetes education and support by telemedicine |
|
| Usual care | Active Comparator | Diabetes education and support in person |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hospital telemedicine management system | Device | Patients upload data of blood glucose, diet and exercise. Then doctors guide patients' diet, exercise and medication adjustment through the telemedicine system. |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose control (HbA1c levels) | Change in HbA1c among control and telemedicine groups from baseline to 6 months | Baseline, 22days,3 months and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in FBG | Change in FBG among control and telemedicine groups from baseline to 6 months | Baseline, 22days,3 months and 6 months |
| Change in Blood glucose 2 hours after breakfast | Change in Blood glucose 2 hours after breakfast among control and telemedicine groups from baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in scores measured by Self-rating Depression Scale | Self-rating Depression Scale includes 20 items in four dimensions of psychological disorders, namely, psychotic emotional symptoms, somatic disorders, psychomotor disorders, and depression. The maximum value of SDS is 50 points. A lower total score means a better situation in terms of depression and vice versa | Baseline, 22days,3 months and 6 months |
Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenwen Yin, MD. | Contact | +86 18112008016 | wenwen261621@163.com | |
| Ning Ding, MD. | Contact | +86 17712987026 | 961897477@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Endocrinology, Xuzhou NO.1 Peoples Hospital | Recruiting | Xuzhou | Jiangsu | 221000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36174028 | Derived | Yin W, Liu Y, Hu H, Sun J, Liu Y, Wang Z. Telemedicine management of type 2 diabetes mellitus in obese and overweight young and middle-aged patients during COVID-19 outbreak: A single-center, prospective, randomized control study. PLoS One. 2022 Sep 29;17(9):e0275251. doi: 10.1371/journal.pone.0275251. eCollection 2022. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Usual care | Other | Outpatient/telephone follow-up：continued care, as usual, from their primary care provider through out duration of action 6 months intervention period |
|
| Baseline, 22days,3 months and 6 months |
| Change in Blood pressure | Change in Blood pressure among control and telemedicine groups from baseline to 6 months | Baseline, 22days,3 months and 6 months |
| Body mass BMI changes | Comparison of BMI changes among control and telemedicine groups from baseline to 6 months | Baseline, 22days,3 months and 6 months |
| Change in waist-to-hip ratio | Comparison of waist-to-hip ratio changes among control and telemedicine groups from baseline to 6 months | 6 months |
| Change in biological parameter: TC | Variation between baseline to 6 months of Biological parameter among control and telemedicine groups: TC | Baseline, 22days,3 months and 6 months |
| Change in biological parameter: TG | Variation between baseline to 6 months of Biological parameter among control and telemedicine groups: TG | Baseline, 22days,3 months and 6 months |
| Change in biological parameter: HDL-C | Variation between baseline to 6 months of Biological parameter among control and telemedicine groups: HDL-C | Baseline, 22days,3 months and 6 months |
| Change in biological parameter: BUN | Variation between baseline to 6 months of Biological parameter among control and telemedicine groups: BUN | Baseline, 22days,3 months and 6 months |
| Change in biological parameter: Scr | Variation between baseline to 6 months of Biological parameter among control and telemedicine groups: Scr | Baseline, 22days,3 months and 6 months |
| Change in biological parameter: e-GFR | Variation between baseline to 6 months of Biological parameter among control and telemedicine groups: e-GFR | Baseline, 22days,3 months and 6 months |
| Number of hypoglycemia events | Hypoglycemia events for telemedicine group versus control group | 6 months |
| Cost effectiveness | The objectives are to compare the results of the study in terms of cost and cost-effectiveness of these two strategies | 6 months |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |